Circuitry Assessment and Reinforcement Training Effects on Recovery (CARTER)

Circuitry Assessment and Reinforcement Training Effects on Recovery (CARTER)

This study investigates if electroencephalography (EEG) neurofeedback training is more beneficial than sham feedback training for the improvement of communication, anxiety, and sleep quality in individuals with aphasia. Half of the participants will receive active EEG neurofeedback sessions first, followed by sham feedback sessions in a crossover design. The other half of participants will undergo sham feedback sessions first, followed by active neurofeedback.

Study Overview

• Status: Suspended
• Conditions: Stroke; Primary Progressive Aphasia; Aphasia
• Intervention / Treatment: Device: EEG Neurofeedback; Device: Sham Feedback

Detailed Description

Neurofeedback, a form of biofeedback, provides a visual and/or audio representation of an individual's neural electrical activity from live EEG recording. Using operant conditioning principles, individuals are trained to increase or reduce patterns of brainwave activity to modify behavior and performance. Although neurofeedback has not yet been investigated as a treatment for aphasia or other communication deficits due to stroke or neurodegenerative disease, it may be effective. Previous studies have observed improvement in cognitive and behavioral measures in those with conditions such as Attention Deficit Disorder and Attention Deficit Hyperactivity Disorder. Furthermore, it has been associated with reduced anxiety and sleep disruption, which both exacerbate language and communication impairments. Research is needed to determine if neurofeedback may be an effective treatment for language disorders such as PPA and post-stroke communication disorders.

It is possible that EEG neurofeedback, which focuses on improving abnormal brainwave patterns, could provide certain therapeutic benefits to individuals with PPA or post-stroke aphasia, either by directly affecting neural networks that underlie language, or more generally by reducing anxiety and inattention through behavioral conditioning. Reduction of anxiety in neurological diseases can be beneficial not only for functional performance but also sleep duration and quality.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of PPA or aphasia secondary to stroke and presence of naming deficits with confirmation of diagnosis by neurologist
• Capable of giving informed consent or indicating another to provide informed consent
• Age 18 or older.
• If aphasia is secondary to stroke, the stroke must have occurred between 6 months and 5 years prior to enrollment in the study.

Exclusion Criteria:

• Lack of English proficiency
• Not medically stable
• Picture naming accuracy above 80% on the Philadelphia Naming Test (PNT)
• Prior history of neurologic disease affecting the brain (e.g., brain tumor, multiple sclerosis, traumatic brain injury) other than stroke or PPA and its underlying neurological pathologies: Alzheimer's Disease, Frontotemporal Lobar Degeneration or Dementia with Lewy bodies
• Prior history of severe psychiatric illness, developmental disorders or intellectual disability (e.g., PTSD, major depression, bipolar disorder, schizophrenia, obsessive compulsive disorder (OCD), autism spectrum disorders)
• Uncorrected severe visual loss or hearing loss by self-report and medical records

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active EEG Neurofeedback; 15 sessions of active EEG neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.	Device: EEG Neurofeedback; Active EEG neurofeedback
Sham Comparator: Sham Feedback; 15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.	Device: Sham Feedback; Sham EEG feedback sessions identical to active sessions except that the feedback given to the participant will not be based on the individual's live EEG activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Number of content units expressed in the Picture Description Test	Change in Number of content units expressed by the participant when describing what is seen in a picture.	Baseline, 1 week following each intervention period and 8 weeks following both intervention periods

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of items correctly named on the Philadelphia Naming Test	Change in number of items correctly named on a behavioral picture naming assessment.	Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
Change in Controlled Oral Word Association test (COWA) score	This is a measure of attention, executive function, and word-retrieval. COWA scores range from 0 to infinity. Lower scores represent more language impairment.	Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
Change in quality of sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI)	Change in quality of sleep measured with The Pittsburgh Sleep Quality Index (PSQI). This has 7 items with each item scored from 0 to 3. Overall score ranges from 0 to 21 with higher scores representing poor sleep quality.	Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
Change in anxiety as assessed by the State Trait Anxiety Inventory (STAI)	Change in anxiety measured with State Trait Anxiety Inventory. This is a 40-item questionnaire scored on a 4 point likert scale (1-4). Overall score ranges from 40 to 160 with higher scores representing greater anxiety.	Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
Change in Sleep Medication Dose	Change in dose of sleep medication.	Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
Change in Sleep Medication Frequency	Change in frequency of sleep medication.	Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
Change in absolute power on EEG	Measurement of brainwave activity (absolute power in microvolts) in each frequency band (alpha, beta, theta, delta, gamma) on Quantitative EEG (qEEG).	Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
Change in peak amplitude frequency on EEG	Measurement of brainwave activity (peak amplitude frequency in hertz) in each frequency band (alpha, beta, theta, delta, gamma) on qEEG.	Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
Change in EEG absolute power z-scores	Comparison of z-scores for absolute power in each of the frequency bands (alpha, beta, theta, delta, gamma) pre- and post-interventions.	Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
Change in EEG peak amplitude frequency z-scores	Comparison of z-scores for peak amplitude frequency in each of the frequency bands (alpha, beta, theta, delta, gamma) pre- and post-interventions.	Baseline, 1 week following each intervention period and 8 weeks following both intervention periods
Change in EEG coherence z-scores	Comparison of z-scores for coherence between EEG sites in each of the frequency bands (alpha, beta, theta, delta, gamma).	Baseline, 1 week following each intervention period and 8 weeks following both intervention periods

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Argye E Hillis, MD, MA, Johns Hopkins School of Medicine

Publications and helpful links

General Publications

• Banerjee S, Argaez C. Neurofeedback and Biofeedback for Mood and Anxiety Disorders: A Review of Clinical Effectiveness and Guidelines [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2017 Nov 13. Available from http://www.ncbi.nlm.nih.gov/books/NBK531603/
• Berube S, Nonnemacher J, Demsky C, Glenn S, Saxena S, Wright A, Tippett DC, Hillis AE. Stealing Cookies in the Twenty-First Century: Measures of Spoken Narrative in Healthy Versus Speakers With Aphasia. Am J Speech Lang Pathol. 2019 Mar 11;28(1S):321-329. doi: 10.1044/2018_AJSLP-17-0131.
• Collura, T. (2014). Technical foundations of neurofeedback. New York: Taylor and Francis.
• Fuchs T, Birbaumer N, Lutzenberger W, Gruzelier JH, Kaiser J. Neurofeedback treatment for attention-deficit/hyperactivity disorder in children: a comparison with methylphenidate. Appl Psychophysiol Biofeedback. 2003 Mar;28(1):1-12. doi: 10.1023/a:1022353731579.
• Hetkamp M, Bender J, Rheindorf N, Kowalski A, Lindner M, Knispel S, Beckmann M, Tagay S, Teufel M. A Systematic Review of the Effect of Neurofeedback in Cancer Patients. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419832361. doi: 10.1177/1534735419832361.
• Nan W, Dias APB, Rosa AC. Neurofeedback Training for Cognitive and Motor Function Rehabilitation in Chronic Stroke: Two Case Reports. Front Neurol. 2019 Jul 24;10:800. doi: 10.3389/fneur.2019.00800. eCollection 2019.
• Wang SY, Lin IM, Fan SY, Tsai YC, Yen CF, Yeh YC, Huang MF, Lee Y, Chiu NM, Hung CF, Wang PW, Liu TL, Lin HC. The effects of alpha asymmetry and high-beta down-training neurofeedback for patients with the major depressive disorder and anxiety symptoms. J Affect Disord. 2019 Oct 1;257:287-296. doi: 10.1016/j.jad.2019.07.026. Epub 2019 Jul 5.

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2020
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): March 2, 2020

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: neurofeedback; sleep; communication; anxiety; language; speech
• Additional Relevant MeSH Terms: Mental Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Dementia; Language Disorders; Communication Disorders; Speech Disorders; Frontotemporal Lobar Degeneration; Aphasia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
• Other Study ID Numbers: IRB00242136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes